Supplements: Market virtually unregulated

Let the buyer beware — dietary and health supplements are not given the stamp of approval by the government before the products hit the shelves.

KEN McMILLAN

Let the buyer beware — dietary and health supplements are not given the stamp of approval by the government before the products hit the shelves.

The burden of proof for the accurate labeling and validity of health claims fall upon the manufacturer. The Food and Drug Administration only steps in when a manufacturer self-reports a problem or enough consumer health concerns are raised. The FDA also will conduct spot checks of some products.

Prior to 1994, dietary supplements had to meet the same regulatory requirements as other foods. Following heavy lobbying efforts by the supplements industry, President Clinton signed the Dietary Supplement Health and Education Act in October 1994.

That Act declares manufacturers responsible for making sure their products are safe and develop evidence for proof, but they do not have to issue any reports to the FDA prior to or after release to the public.

"Dietary supplements do not need approval from FDA before they are marketed," said Siobhan Delancey of the FDA.

Consumer Reports magazine claims the act takes away protections that would be demanded of drugmakers. Supplements are considered food, not medication.

Essentially, the manufacturer says the product is safe, and the FDA has no choice but to say, "OK, we'll see."

The lone high-profile product the FDA was able to take off the market was the weight-loss and energy supplement ephedra.

As a means to keep closer tabs, in June 2007 the FDA issued stringent regulations called the Current Good Manufacturing Practices, which are supposed to ensure the identity, purity, quality, strength and composition of dietary supplements by June 2010.

Enforcement of the regulations is more difficult as the number of FDA investigators dropped 16 percent between 2003 and 2006.

"The FDA utilizes its available resources to best address risks to the public health," Delancey said. "If Congress chose to provide the agency with greater funding, we would make the best possible use of those resources."

The FDA requested a budget of $3.2 billion for year 2010, or $511 million more than 2009 — the 19 percent increase is the largest ever in FDA history.

With headquarters in Silver Spring, Md., the FDA has 223 field offices and 13 labs throughout the U.S., Puerto Rico and U.S. Virgin Islands. The FDA regulates more than $1 trillion worth of consumer goods, roughly a quarter of all consumer expenditures.

"FDA's enforcement challenges are discovering the violation in a huge universe of dietary supplements, proving the violation, and effectively deterring future bad actors," Delancey said. "After products enter the market, FDA must undertake intensive investigative and analytical processes to show that they are violative. Each enforcement action involves a collaborative effort by FDA chemists, laboratory staff, lawyers, physicians and investigators that can span many months."

Between Jan. 1, 2008, and Sept. 11, 2009, the FDA received 1,052 cases reported as serious adverse events. Of those cases, 36 percent dealt with gastrointestinal disorder events and 33 percent were classified as general system disorder events, such as asthenic conditions, gait disturbances, pain, discomfort and edema.

However, the findings in these case studies are not totally reliable because individuals may have used other products, and supplements may contain multiple ingredients.

"We have a very strong compliance and enforcement team that will not hesitate to take action against manufacturers of violative products," Delancey said.

kmcmillan@th-record.com

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